Pure genius

Cleanroom technology has become both essential and expected by device manufactures and moulders in the medical industry today. This technology works to control the level of contamination to create a sterile manufacturing environment. Styron, a global manufacturer of plastics, latex and rubber, utilises cleanroom technology at its polycarbonate manufacturing facility in Stade, Germany. The company’s Calibre polycarbonate resins play a vital role in the production of applications such as syringes, insulin pens, surgical instruments, and dialyser housings. Using cleanroom technology at both the material production and packaging level, Styron is able to minimise the risk of foreign contamination in its polycarbonate resins and provide customers with a superior product and an industry-recognized level of cleanliness.

In the past, clean room technology for medical applications was mainly utilised in the fabrication and assembly stages, yet it is now becoming increasingly important in the material production process as well. Device manufacturers demand the highest-quality products, free of defects and contaminants, with many applications requiring a tolerance level of “0” for defects in material composition. Cleanroom technology meets these stringent requirements and as a result, resins produced in a cleanroom environment are in high demand throughout the medical industry.

Cleanroom technology is especially essential in activities where cross contamination can occur. As a result, Styron has implemented the use of cleanroom technology in three separate areas at its Stade facility - extruder (resin processing); laboratory (resin compounding) and packaging (pellet transfer and final packaging).

Styron takes many precautions in maintaining its cleanroom facilities for the production of its polycarbonate resin grades. Operators are given comprehensive instruction on cleanroom procedures and are required wear full-body dust gowns with shoe and head covers in dedicated changing rooms. They wear a new clean suit for each shift and damaged suits are disposed of. Styron has implemented a monitoring system to collect temperature, humidity, pressure and particle count data in each cleanroom area. The data is collected and stored in a standalone personal computer that is alarmed to alert operators if the measured value of particulate matter is outside the specified limits. In addition, a light signal notifies the control room operator of the status to ensure operations are within parameters at all times.